2,057 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·COBAS TaqMan HBV Test for Use with the High Pure System and COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-MAK-2 PLUS ASSAY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IMMUNOASSAY ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR HBSAG
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR HBC IGM ASSAY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATORS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·DiaSorin ETI-EBK PLUS assay
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS & CALIBRATORS
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·CERVISTA HPV HR COMPONENTS
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·ABBOTT REALTIME HBV ASSAY, CALIBRATOR KIT, CONTROL KIT; ABBOTT MSAMPLE PREPARATION SYSTEMDNA.
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·Cobas TaqMan HBV Test v2.0
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE-M
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·BIO-RAD MONOLISA ANTI-HBC EIA
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·ABBOTT REALTIME HBV ASSAY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON Murex Anti-HBc and LIAISON Murex Control Anti-HBc
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-MAK-2 PLUS and HBsAg Confirmatory Test assays
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
FDA Pre-Market Approval
FDA Class 3
·LIAISON QuantiFERON-TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
FDA Pre-Market Approval
FDA Class 3
·LIAISON QuantiFERON-TB Gold Plus; LIAISON Control QuantiFERON-TB Gold Plus
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·HBE RIA DIAGNOSTIC KIT